SAB Biotherapeutics Announces Completion of Enrollment in Phase 2a Challenge Trial of SAB-176 for the Treatment of Seasonal Influenza

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SAB-176 is a novel anti-influenza human immunotherapy designed to address the limitations of current treatments for moderate to severe seasonal influenza.

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Wednesday, September 15, 2021
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Biotechnology, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, BCYP, Form, CDC, Immunotherapy, Government, SAB, Private Securities Litigation Reform Act, Forward-looking statement, A type, Prospectus, Genetic engineering, Doctor of Philosophy, Patient, Proxy, Viral load, Register, Securities Act of 1933, Risk, Influenza, Big Cypress National Preserve, Use-centered design, Probability, Safety, Infection, Vaccine, NASDAQ, Communication, TC, COVID-19, Twitter, Name, Population, Real-time, Registration statement, SEC, Organ transplantation, Sale, Cancer, SAB-176, Seasonal Influenza, SAB Biotherapeutics, Inc., SAB-176, SEASONAL INFLUENZA, SAB BIOTHERAPEUTICS, INC.
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Summary
Key Points: 
  • SAB-176 is a novel anti-influenza human immunotherapy designed to address the limitations of current treatments for moderate to severe seasonal influenza.
  • The Phase 2a clinical trial is a randomized, double-blind, placebo-controlled study that is evaluating the safety and treatment efficacy of SAB-176 in 60 healthy adults challenged with a pandemic influenza virus strain (pH1N1).
  • SAB-176 is also currently being evaluated in a Phase 1 ascending dose, double-blind, randomized, placebo-controlled safety trial in healthy volunteers, which has also completed enrollment.
  • SAB Biotherapeutics, Inc. (SAB) is a clinical-stage, biopharmaceutical company advancing a new class of immunotherapies leveraging fully human polyclonal antibodies.


SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies without the need for human donors, today announced the completion of enrollment in its Phase 2a clinical trial evaluating the safety and efficacy of SAB-176 in a challenge study. SAB-176 is a novel anti-influenza human immunotherapy designed to address the limitations of current treatments for moderate to severe seasonal influenza. It is a high-potency multivalent human polyclonal antibody therapeutic designed specifically to treat or prevent Type A and Type B seasonal and pandemic influenza virus infections, including emerging and mutating strains.

“Achieving full enrollment in the Phase 2a study of SAB-176 marks a milestone in advancing our growing clinical pipeline and reflects progress toward our goal of successfully developing our unique therapeutic candidate, which has demonstrated the potential to overcome key limitations of previous and current treatments for seasonal influenza,” said Eddie J. Sullivan, PhD, co-Founder, President, and Chief Executive Officer of SAB Biotherapeutics. “These include its ability to simultaneously target Type A and B influenza, including emerging and mutating strains, to potentially offer a more effective treatment option than current antivirals, and to provide additional prophylaxis protection for high-risk populations. The recent surge of COVID-19 cases worldwide highlights the importance of addressing other highly-mutating viruses like influenza that may exacerbate the impact of pandemics.”

The Phase 2a clinical trial is a randomized, double-blind, placebo-controlled study that is evaluating the safety and treatment efficacy of SAB-176 in 60 healthy adults challenged with a pandemic influenza virus strain (pH1N1). The primary endpoint of the study is viral load of subjects treated with SAB-176 compared to placebo at 28 days as measured by qRT-PCR nasal samples. For more information on the study, visit clinicaltrials.gov (Identifier: NCT04850898).

SAB-176 is also currently being evaluated in a Phase 1 ascending dose, double-blind, randomized, placebo-controlled safety trial in healthy volunteers, which has also completed enrollment.

On June 22, 2021, SAB announced a planned merger with Big Cypress Acquisition Corp. (NASDAQ: BCYP). The transaction is expected to close in the fourth quarter of 2021.

About SAB-176

SAB-176 is a multivalent, broadly neutralizing fully-human polyclonal antibody therapeutic candidate in development for the treatment or prevention of severe influenza. The novel, specifically-targeted therapeutic leverages the natural human biological immune response to specifically bind to Type A and Type B influenza viruses. Like vaccines, it can also be modified to address annual strain changes when needed. Preclinical data suggests that SAB-176 offers broad protection against diverse influenza strains.

About Seasonal Influenza

According to the US Centers for Disease Control (CDC), on average about 8% of the US population gets sick from flu each season and between 12,000 and 61,000 infected Americans die, depending on the severity of the season. In 2019-2020, considered a moderate flu season, 38 million people in the US became ill with the flu, 18 million saw a healthcare provider for treatment, 400,000 were hospitalized and an estimated 22,000 died. Globally, there are between 2.5 and 5 million influenza-related hospitalizations per year. The CDC recommends an annual flu shot for almost everyone over the age of six months, but each year less than half the population is vaccinated. In addition, because influenza viruses are highly mutating, the vaccines have varying levels of protection in any year, but rarely exceed 50% protection. Young children, the elderly, immune-compromised individuals and patients with chronic health conditions are especially at risk of poor outcomes from influenza.

About SAB Biotherapeutics, Inc.

SAB Biotherapeutics, Inc. (SAB) is a clinical-stage, biopharmaceutical company advancing a new class of immunotherapies leveraging fully human polyclonal antibodies. SAB has applied advanced genetic engineering and antibody science to develop transchromosomic (Tc) Bovine™ herds that produce fully-human antibodies targeted at specific diseases, including infectious diseases such as COVID-19 and influenza, immune system disorders including type 1 diabetes and organ transplantation, and cancer. SAB’s versatile DiversitAb™ platform is applicable to a wide range of serious unmet needs in human diseases. It produces natural, specifically targeted, high-potency, human polyclonal immunotherapies. SAB is currently advancing multiple clinical programs and has a number of collaborations with the US government and global pharmaceutical companies. For more information on SAB, visit: http://www.sabbiotherapeutics.com and follow @SABBantibody on Twitter.

Forward-Looking Statements

Certain statements made herein that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, the development of SAB-185, and the proposed business combination between Big Cypress and SAB. These statements are based on the current expectations of SAB and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on, by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict, will differ from assumption and are beyond the control of SAB.

Additional Information and Where to Find It

Big Cypress has publicly filed a registration statement on Form S-4 with the SEC (the “Registration Statement”), which will include a preliminary prospectus and preliminary proxy statement. Big Cypress intends to mail a definitive proxy statement/final prospectus and other relevant documents to its stockholders. This communication is not a substitute for the Registration Statement, the definitive proxy statement/final prospectus or any other document that Big Cypress will send to its stockholders in connection with the proposed business combination. Investors and security holders of Big Cypress are advised to read, when available, the proxy statement/prospectus in connection with Big Cypress’ solicitation of proxies for its special meeting of stockholders to be held to approve the proposed business combination (and related matters) because the proxy statement/prospectus will contain important information about the proposed business combination and the parties to the proposed business combination. The definitive proxy statement/final prospectus will be mailed to stockholders of Big Cypress as of a record date to be established for voting on the proposed business combination. Stockholders will also be able to obtain copies of the proxy statement/prospectus, without charge, once available, at the SEC’s website http://www.sec.gov or by directing a request to [email protected].

Participants in the Solicitation

Big Cypress, SAB and their respective directors, executive officers, other members of management, and employees, under SEC rules, may be deemed to be participants in the solicitation of proxies of Big Cypress’ stockholders in connection with the proposed business combination. Investors and security holders may obtain more detailed information regarding the names and interests in the proposed business combination of Big Cypress’ directors and officers in Big Cypress’ filings with the SEC including the Registration Statement that has been submitted to the SEC by Big Cypress, once finalized, which will include the proxy statement of Big Cypress for the proposed business combination, and such information and names of SAB’s directors and executive officers also be in the Registration Statement submitted to the SEC by Big Cypress, which will include the proxy statement of Big Cypress for the proposed business combination.

Non-Solicitation

This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the potential transaction and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of Big Cypress or SAB, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.

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